AccessGUDID - DEVICE: TPHA Screen Positive Control and TPHA Screen Negative Control (10888234001508)

GUDID

Device Identifier (DI) Information

Brand Name: TPHA Screen Positive Control and TPHA Screen Negative Control
Version or Model: 0066828
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0066828
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234001508
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: TPHA Screen Positive Control and TPHA Screen Negative Control are run controls used in the TPHA Screen on an automated Blood Bank system. The product configuration is one (1) vial of each control.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
51817	Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYR	Test,Donor,Syphilis,Antigens,Treponemal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 1 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f3adb902-ef46-47cc-8f7b-a0ad35a0a1a7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 15, 2016